Identity
- Device Name
- ECG200+ EUDAMED
- Model / Reference
- 80608068S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732652149 EUDAMED
- Basic UDI-DI
- B-08056732652149 EUDAMED
- EMDN Code
- Z12050302 ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ecg200+ by Cardioline Spa — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160840 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056732652149 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (2)
- EUDAMED 0a6c91dc-ceb9-4a13-945e-293e454fba1c 61 fields · synced Jul 20, 2026
- FDA 510(k) K160840 1 fields · synced May 18, 2026